Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network), 28954-28955 [2020-10353]
Download as PDF
<![CDATA[
28954
Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
Recordkeeping: As noted previously,
section 417(g) of the FD&C Act requires
that responsible persons maintain
records related to reportable foods
reports and notifications for a period of
2 years. Based on past FDA experiences,
we estimate that each mandatory report
and its associated notifications requires
30 minutes of recordkeeping for the 2year period, or 15 minutes per record
per year. The annual recordkeeping
burden for mandatory reportable food
reports and their associated
notifications is thus estimated to be 300
hours (1,200 × 0.25 hours).
We do not expect that records will
always be kept in relation to voluntary
reportable food reports. Therefore, we
estimate that records will be kept for 4
voluntary reports we expect to receive
annually. The recordkeeping burden
associated with voluntary reports is thus
estimated to be 1 hour annually (4 ×
0.25 hours). The estimated total annual
recordkeeping burden is 301 hours
annually (1,200 × 0.25 hours) + (4 × 0.25
hours). This annual burden is shown in
table 2.
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by June 15,
2020.
Dated: April 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2020–10351 Filed 5–13–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0084]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Adverse Event
Program for Medical Devices (Medical
Product Safety Network)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0471. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Adverse Event Program for Medical
Devices (Medical Product Safety
Network (MedSun))—OMB Control
Number 0910–0471—Extension
Section 519 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360i) authorizes FDA to require (1)
manufacturers to report medical devicerelated deaths, serious injuries, and
malfunctions; and (2) user facilities to
report device-related deaths directly to
manufacturers and FDA and serious
injuries to the manufacturer. Section
213 of the Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115) amended section
519(b) of the FD&C Act relating to
mandatory reporting by user facilities of
deaths, serious injuries, and serious
illnesses associated with the use of
medical devices. This amendment
legislated the replacement of universal
user facility reporting by a system that
is limited to a ‘‘. . .subset of user
facilities that constitutes a
representative profile of user reports’’
for device-related deaths and serious
injuries. This amendment is reflected in
section 519(b)(5)(A) of the FD&C Act.
This legislation provides FDA with the
opportunity to design and implement a
national surveillance network,
composed of well-trained clinical
facilities, to provide high-quality data
on medical devices in clinical use. This
system is called the Medical Product
Safety Network (MedSun).
FDA is seeking OMB clearance to
continue to use electronic data
collection to obtain the information on
Form FDA 3500A (approved under
OMB control number 0910–0291)
related to medical devices and tissue
products from the user facilities
participating in MedSun, to obtain a
demographic profile of the facilities,
and for additional questions, which will
permit FDA to better understand the
cause of reported adverse events.
Participation in the program is
voluntary and includes approximately
300 facilities.
In addition to collecting data on the
electronic adverse event report form,
MedSun collects additional information
from participating sites about reported
problems emerging from the MedSun
hospitals. This data collection is also
voluntary and is collected on the same
website as the report information.
The burden estimate is based on the
number of facilities participating in
MedSun (300). FDA estimates an
average of 18 reports per site annually.
This estimate is based on MedSun
working to promote reporting in general
from the sites, as well as promoting
reporting from specific parts of the
hospitals, such as the pediatric
intensive care units, the
electrophysiology laboratories, and the
hospital laboratories.
In the Federal Register of September
20, 2019 (84 FR 49526), we published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was received
offering general support for the
collection but offered no suggested
changes to the burden estimate.
We estimate the burden of this
collection of information as follows:
jbell on DSKJLSW7X2PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Adverse event reporting .................................................
1 There
Number of
responses per
respondent
300
18
Average
burden per
response
Total annual
responses
5,400
0.50 (30 minutes)
are no capital costs or operating and maintenance costs associated with this collection of information
VerDate Sep<11>2014
18:29 May 13, 2020
Jkt 250001
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
E:\FR\FM\14MYN1.SGM
14MYN1
Total hours
2,700
Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
Our estimated burden for the
information collection reflects an
overall decrease of 113 hours despite a
corresponding increase of 1,650
responses. We attribute this adjustment
to an increase in the number of
submissions we received over the last
few years but a decrease in the amount
of time spent entering data due to IT
efficiencies that have been built into the
MedSun reporting system to reduce data
entry by user facilities.
Dated: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10353 Filed 5–13–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0275]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Certification to
Accompany Drug, Biological Product,
and Device Applications or
Submissions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the requirements for certain FDA
applications or submissions to be
accompanied by a certification, Form
FDA 3674, to ensure all applicable
statutory requirements have been met.
DATES: Submit either electronic or
written comments on the collection of
information by July 13, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 13, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of July 13, 2020. Comments
received by mail/hand delivery/courier
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:29 May 13, 2020
Jkt 250001
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–N–0275 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Certification to Accompany Drug,
Biological Product, and Device
Applications or Submissions.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
28955
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
E:\FR\FM\14MYN1.SGM
14MYN1
]]>Agencies
[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28954-28955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10353]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0084]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Adverse Event Program
for Medical Devices (Medical Product Safety Network)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by June 15, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0471. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Adverse Event Program for Medical Devices (Medical Product Safety
Network (MedSun))--OMB Control Number 0910-0471--Extension
Section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360i) authorizes FDA to require (1) manufacturers to report
medical device-related deaths, serious injuries, and malfunctions; and
(2) user facilities to report device-related deaths directly to
manufacturers and FDA and serious injuries to the manufacturer. Section
213 of the Food and Drug Administration Modernization Act of 1997 (Pub.
L. 105-115) amended section 519(b) of the FD&C Act relating to
mandatory reporting by user facilities of deaths, serious injuries, and
serious illnesses associated with the use of medical devices. This
amendment legislated the replacement of universal user facility
reporting by a system that is limited to a ``. . .subset of user
facilities that constitutes a representative profile of user reports''
for device-related deaths and serious injuries. This amendment is
reflected in section 519(b)(5)(A) of the FD&C Act. This legislation
provides FDA with the opportunity to design and implement a national
surveillance network, composed of well-trained clinical facilities, to
provide high-quality data on medical devices in clinical use. This
system is called the Medical Product Safety Network (MedSun).
FDA is seeking OMB clearance to continue to use electronic data
collection to obtain the information on Form FDA 3500A (approved under
OMB control number 0910-0291) related to medical devices and tissue
products from the user facilities participating in MedSun, to obtain a
demographic profile of the facilities, and for additional questions,
which will permit FDA to better understand the cause of reported
adverse events. Participation in the program is voluntary and includes
approximately 300 facilities.
In addition to collecting data on the electronic adverse event
report form, MedSun collects additional information from participating
sites about reported problems emerging from the MedSun hospitals. This
data collection is also voluntary and is collected on the same website
as the report information.
The burden estimate is based on the number of facilities
participating in MedSun (300). FDA estimates an average of 18 reports
per site annually. This estimate is based on MedSun working to promote
reporting in general from the sites, as well as promoting reporting
from specific parts of the hospitals, such as the pediatric intensive
care units, the electrophysiology laboratories, and the hospital
laboratories.
In the Federal Register of September 20, 2019 (84 FR 49526), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received offering general
support for the collection but offered no suggested changes to the
burden estimate.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adverse event reporting....................... 300 18 5,400 0.50 (30 minutes)....................... 2,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information
[[Page 28955]]
Our estimated burden for the information collection reflects an
overall decrease of 113 hours despite a corresponding increase of 1,650
responses. We attribute this adjustment to an increase in the number of
submissions we received over the last few years but a decrease in the
amount of time spent entering data due to IT efficiencies that have
been built into the MedSun reporting system to reduce data entry by
user facilities.
Dated: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10353 Filed 5-13-20; 8:45 am]
BILLING CODE 4164-01-P
